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OpenTrials
Completed

NCT Number: NCT00496418

Peristomal Mesh for Prophylaxis of Parastomal Hernia

The study aims to prove differences or equalities in outcome for patients operated with or without a peristomal mesh in the sublay position when establishing a permanent colostomy.

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Key information

Conditions

Hernia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Rikshospitalet-Radiumhospitalet HF

Oslo, NO-0027, Norway

About this study

Patients are randomized to 2 groups equal in number: a group with mesh implantation and a control group without mesh implantation.

Primary endpoint is Parastomal hernia. Secondary endpoints are operating time, infection, obstruction, stenosis, retraction, fistulae, skin related problems and reoperations. Endpoints are correlated to body mass index, previous hernia, age, concurrent illness and cause for colostomy. Patients are followed 4 years after operation with clinical examination

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Condition with indication for establishing a permanent end-colostomy.

Exclusion criteria

  • Age under 18
  • ASA score above 3

Treatment and study plan

Mesh in permanent colostomy

Device

Primary outcomes

  1. Parastomal hernia

    Time frame: at 3, 12, 24, 36 and 48 months

Secondary outcomes

  1. Operating time, infection, obstruction, stenosis, retraction, fistulae, skin related problems and reoperations. Endpoints are correlated to body mass index, previous hernia, age, concurrent illness and cause for colostomy

    Time frame: 4 years

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

Randomized Controlled Open Interventional Study for Evaluation of Use of Peristomal Mesh for Prophylaxis of Parastomal Hernia

Important dates

Study start
2007
Primary completion
2011
Study completion
2014
First posted
Jul 4, 2007
Registry last updated
Jan 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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